ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 — Class II medical device recall Z-2320-2019
Terminated recall by Radiometer America Inc, reported 2019-08-28, distributed in AL, AR, CA, CO, CT, FL, GA, IA…. Software Security; The action is being initiated because of software security vulnerabilities with the firm's
| Recall number | Z-2320-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2019-07-10 |
| Classified | 2019-08-22 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2022-06-13 |
| Distributed | AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV |
| Countries outside the US | AT, AU, BR, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, IT, JP, KR, MX, NO, PL, SE, SG, TR, ZA |
| Quantity | 13,042 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05700693930909 |
| Model numbers | 393090 |
Product
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Reason for recall
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2320-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.